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Company SOTAX, founded in 1973, began as an engineering company to service the pharmaceutical and other industries. Today SOTAX is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry. SOTAX is owned privately by the Benz family.
Worldwide, SOTAX has a staff of over 140 skilled and motivated employees. Its headquarter is in Allschwil, near Basel, the center of the pharmaceutical industry in Switzerland: manufacturing, engineering, research and development, as well as administration, sales and marketing departments are all located there together with a demo and application laboratory as well as an auditorium for conferences and seminars. SOTAX has sales and service organizations in Canada, China, France, Germany, Great Britain, Italy, Switzerland and the USA and is represented in other markets through local distributors. The US organization is located in Hopkinton, Massachusetts, with administration, demo and application laboratory, maintenance center and warehouse. SOTAX Corporation has a network of sales and service specialists throughout Canada and the USA.
SOTAX has established an excellent international reputation as a specialist in the development and production of sophisticated test equipment and automated systems. We work with major pharmaceutical companies to develop customized hardware/ software solutions for their products. Our management focuses on very high quality standards in all operation levels and is continuously improving the quality of its systems to meet GMP, GAMP and ISO 9000-3 standards. In 1996 SOTAX received the ISO 9001 Certification, extended in 1999 to the TickIT Quality system for software development, thereby becoming the world’s first supplier of dissolution testing systems to receive this seal of quality. SOTAX instruments meet all CP, EP, JP, USP and FDA Guidelines and SOTAX Softwares allow full compliance to 21 CFR part 11.
SOTAX also offers SPS Pharma Services (CRO), contract research lab dedicated to dissolution testing research, method development and advanced training. In 2008, SOTAX integrated the Zymark® automation product line, resources and services. With the addition of the Hopkinton facility in Massachusetts, customers benefit from SOTAX’s increase US and global presence and network of direct sales and services.
SOTAX also offers its know-how as a service to the pharmaceutical industry, including installations, maintenance and repair services as well as a comprehensive and careful validation service in compliance with FDA regulations.
The loyalty displayed by our regular customers in more than 40 countries throughout the world encourages us to continue to deliver the highest quality.
Convincing Solutions for your drug testing
1
Products
Dissolution Testing
USP Apparatus 1, 2, 5 & 6 Page 2 to 7
Fully Automated USP Apparatus 1& 2 Page 8 to 10
Media Preparation Page 11
Filter Station Page 12
Flow-Through Cell USP Apparatus 4 Page 13 to 15
Dissolution Accessories Page 16
Dissolution Software Page 17
Physical Testing
Disintegration Testing Page 22
Hardness Testing Page 23 to 25
Flowability Testing Page 26
Friability Testing Page 27
Tap Density Testing Page 28
Physical Testing Software Page 29
Content, Blend & Assay Testing
Content, Blend & Assay Testing Page 18 to 21
SOTAX Services Page 30 to 31
SOTAX Corporate Mission Page 32
SOTAX Contacts Page 33
The smarter choice for Dissolution testingSOTAX AT 7smart
SOTAX AT 7smart
2
Features & Benefits
Compliant with all Pharmacopeial methods including USP Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 5 (paddle over disk), Apparatus 6 (rotating cylinder), Intrinsic Dissolution, Stationary basket, and Mini Paddles/Baskets/Vessels Fulfills all USP, EP, JP and CP requirements
Seven vessels for 6 samples and 1 placebo or blank solution, staggered vessel design for unobstructed visual observation, built-in heater/circulator Compact and space-saving design, vibration free, easy sample viewing
Fixed position shaft height, automatic vessel centering and built-in evaporation covers Fully conforms to ASTM Mechanical Calibration with low evaporative loss of media
Program dissolution methods in firmware and print reports with built in printer report Program assistance in tablet introduction, sampling times, protocol printout of test parameters incl. temperature, rpm, sampling times for traceability
Tablet introduction assist Simultaneous or staggered tablet introduction
Serialized Shafts, Paddles, Baskets and Vessels with removeable bath and cover plate Easy removal and cleaning of paddles, baskets, vessels and bath. Components identification for validation
Modular concept ready for upgrades to automation with firmware or software control Easy upgrades to automation with addition of autosampler, on-line HPLC, on-line UV-Vis spectrophotometer, UV Fiber Optics or Automated Sampling Device
Sampling port on each vessel Allows manual sampling through height adjustable cannula
SOTAX AT 7smart UV On-line
SOTAX AT 7smart UV On-line
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Automated photometric analysis for Dissolution tests according to USP 1, 2, 5, 6 and intrinsic Dissolution methods
Features & Benefits
Controlled by WinSOTAXplus Advanced Dissolution Software Allows full compliance to 21 CFR part 11 in standalone and client/server modes
Drivers available for several UV-Vis brands Possible use of existing UV-Vis spectrophotometers
Direct sample analysis during the test Dissolution curves available on the fly
Connect two baths to a single UV-Vis Spectrophotometer Enhanced productivity (12 samples)
Automatic sampling through or beside the shaft by Hollow Shaft™ or cannula Complete sampling reproductibility on the six samples and one placebo or blank solution
Simultaneous withdrawing, filtering and analyzing of the six samples and one placebo or blank solution Shortest measuring intervals for determining the release profile
pH change by Media addition and pH monitoring controlled by software Automate time consuming media changes
Compatibility with filter station FS 7 Allows filter changes before each sampling time
HPLC On-line solution for fast UPLC/HPLC methods
SOTAX AT 7smart HPLC On-line
SOTAX AT 7smart HPLC On-line
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Features & Benefits
Automated sample injection or collection Increased productivity
Direct transfer of samples from dissolution bath to LC Elimates manual handling errors
Injections controlled by the external module SOTAX MF 7-LC Compatible with all major brands of HPLC
Designed for rapid direct injection LC methods Can be adapted to UPLC or equivalent systems
Controlled by WinSOTAXplus Advanced Dissolution Software Compatibility with other SOTAX Dissolution systems
Automatic sampling through or beside the shaft by Hollow Shaft™ or cannula Complete sampling reproductibility on the six samples and one placebo or blank solution
Automated sample collection for dissolution tests according to USP 1, 2, 5, 6 and intrinsic Dissolution
SOTAX AT 7smart Off-line
SOTAX AT 7smart Off-line
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Features & Benefits
Semi-automated system based on the AT 7smart, includes a pump CY7-50 and a fraction collector C613 Simultaneously withdrawing, filtering and collecting of the 6 samples and a placebo or a blank solution in open/capped LC vials or open glass tubes at each sampling time
Firmware controlled with comprehensive menus or controlled by WinSOTAXplus Advanced Dissolution Software allowing compliance to 21 CFR part 11 System control flexibility
Connect 2 baths to a single fraction collector Enhanced Productivity (12 samples)
Additional valve for media replacement Sample volumes removed can be replaced by fresh solvent, allowing low volume dissolution profiles
Automatic sampling through or beside the shaft by Hollow Shaft™ or cannula Complete sampling reproductibility on the six samples and one placebo or blank solution
pH change by Media addition and pH monitoring controlled by software Automate time consuming media changes
Compatibility with Filter Station FS 7 Allows filters change before each sampling time
The automatic staggered sampling system for SOTAX AT 7smart
SOTAX AT 7smart ASD
SOTAX AT 7smart ASD
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Features & Benefits
Robotic system integrated with SOTAX AT 7smart Compact space-saving system, upgrades any existing standard AT 7smart
Sample collection into HPLC capped vials No evaporation of the collected samples
No system tubing volume Avoids potential adsorption problems (e.g. adherent products such as hormones)
Firmware controlled method programming and reporting Easy programming
The UV Fiber Optic system designed for Dissolution testing
SOTAX AT 7smart OPT-DISS™
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SOTAX AT 7smart OPT-DISS™
Features & Benefits
Simultaneous In-Situ UV-Vis measurements in 7 vessels No tubing, no pumping, no filtering, no gap time, no dead volume
Controlled by WinSOTAXplus Advanced Dissolution Software Allows full compliance to 21 CFR part 11 in standalone and client/server modes
Uses patented ARCH Probes™ and standard immersion probes Low disturbance open design, prevents excipient buildup, bubble entrapment and provides consistent minimal path-length measurements
CCD Detector optimized for fast UV readings Real simultaneous measurements on 6 channels
No sample removal, filtering or pumps Minimal hydrodynamical effects with ARCH Probes™ with the possibility to run methods developed on standard probes
In-Situ measurements Amazing ability to scan simultaneously on 6 vessels
High volume dissolution testing throughput for paddle methods
SOTAX AT 70smart
SOTAX AT 70smart
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Features & Benefits
Fully automated tablet dissolution system for a series of 10–15 dissolution tests using the USP 2 method 10 to 15 test without any user intervention
Automates the entire dissolution test from media preparation and delivery, sampling, filtering, collection and/or analysis, and vessel cleaning Method transfer from manual to automation with guaranteed reproducibility monitored on every step and complete traceability
Controlled by WinSOTAXplus Advanced Dissolution Software Immediate familiarity for WinSOTAXplus users, same drivers as for semi-automated systems
Media change procedures allow additions, replacement or a full change of media Allows difficult method transfers with pH monitoring and dispensed and added media volume validation
Compatible with a variety of sinker types Allows multiple capsule testing (R&D and QC)
Specific solution for pellets and granulates On-going development for specific USP 2 customers needs
Woldwide Network of dedicated product specialists for support and validation Complete validation IQ, OQ, PQ under Maintenance and Validation contracts
High volume dissolution testing throughput for both paddle and basket methods
SOTAX AT 70 BS 60
SOTAX AT 70 BS 60
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Features & Benefits
The AT 70 BS 60 has all the features of the AT 70smart plus:
Up to 10 dissolution tests for USP 1 methods Maximum throughput on USP 1 and 2 methods
Simultaneous attachment and removal of test baskets Maximal productivity due to minimal inter-test time
Optical sensor confirmation of basket attachment and removal Accurate and reproducible automation process checking potential errors
Short and thorough cleaning cycle for tubes, baskets and vessels Complete cleaning of the systems (tubes, baskets, vessels)
Specific solution for sticky products Unique custom solutions for specific USP 1 methods
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Proven MultiDose® and MultiDose Plus® for fully automated dissolution analysis for paddle and baskets
Zymark MultiDose G3
Features & Benefits
Automate some existing manual dissolution baths Simplifies tedious method transfers from manual to automation
Eight different basket or paddle methods with different requirements within each batch Flexible open architecture allows for a wide variety of applications
Compatible with a wide range of sinkers including Japanese sinkers Easy method transfer from manual to automation even for methods with sinkers
Gravimetric recording of initial vessel volume prior to running method Increased traceability compared to equivalent manual methods
Probe equipped with temperature sensors to measure and record in each vessel at each sampling point Improved efficiency in development compared to equivalent manual bath methods
Zymark® MultiDose G3
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Increased productivity with automated media preparation
SOTAX MPS
SOTAX MPS
Features & Benefits
Dissolution media preparation with a mobile space saving unit Can be moved close to the Dissolution bath location to avoid any vessel or bath displacement
Use of concentrates with on-line preparation or by sequential addition Time and money savings
Automates heating, stirring and vacuum degassing of the dissolution media Improves reproducibility and reliability
Volumetric filling at 1500 ml/min with an accuracy better than 1 % Fast and accurate volume dispensing without glassware
Gravimetric self-calibration option with built-in balance and printer port (optional) Print out volumes dispensed and Calibration reports
Optional tray for media tank holding, protection bars Simplified handling of media tanks
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The SOTAX FS 7 Filter Station for reliable automated filter changes after sampling in semi-automated dissolution systems
SOTAX FS 7
SOTAX FS 7
Features & Benefits
Automates 25 mm luer-lock filter changes after each sampling point Solves saturation and clogging problems
Filter change controlled by AT 7smart firmware or by WinSOTAXplus Advanced Dissolution Software Complete extended and modified release testing and media change methods automation
Allows the use of 0.45 micron porosity 25 mm filters (with the SOTAX CP 7 pump) Complete the SOTAX fraction collector with filtered samples ready for HPLC analysis
Uses SOTAX and Zymark certified Pall™ PSF filters Simplifies filter validations and method transfers to full automation
Compatible with AT 7smart On/Off-line systems Upgrade easily the existing SOTAX semi-automated systems On and Off-line
Storage up to 140 filters and collection tray for dispensed used filters Easy filter handling
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Automated photometric analysis for dissolution tests according to the Flow-through Method (USP 4)
SOTAX CE 7smart UV On-line
SOTAX CE 7smart UV On-line
Features & Benefits
Flow-through cell (Apparatus 4) instrument with pump and UV-Vis spectrophotometer Designed for semi-automatic USP 4 methods with photometric analysis
Cells available for tablets, capsules, powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices Testing of several dosage forms, including novel dosage forms, in dedicated cells
Available in closed and open loop configurations Useful for low dose and poorly soluble formulations
Controlled by WinSOTAXplus Advanced Dissolution Software Allows full compliance to 21 CFR part 11 in standalone and client/server modes
Drivers available for several UV-Vis brands Possible use of existing UV-Vis spectrophotometers
Direct sample analysis during the test Dissolution curves available on the fly
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Open loop off-line with fraction collector for dissolution tests according to the Flow-through Method (USP 4)
SOTAX CE 7smart Off-line open system
SOTAX CE 7smart Off-line open system
Features & Benefits
Flow-Through Cell (Apparatus 4) instrument with pump and fraction collector Designed for semi-automated USP 4 methods in open loop
Cells available for tablets, capsules, powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices Testing of several dosage forms, including novel dosage forms, in dedicated cells
Automated media change with media selector Recommended configuration for media and/or pH changes
Continuous pumping of fresh media with on-line degassing option Ideal for dissolution testing of poorly soluble compounds
Automated fraction collection Flexible sample collection from minutes to months
Controlled by WinSOTAXplus Advanced Dissolution Software or by firmware Allows full compliance to 21 CFR part 11 in standalone and client/server modes
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Closed loop off-line with syringe autosampler for dissolution tests according to the Flow-through Method (USP 4)
SOTAX CE 7smart Off-line closed system
SOTAX CE 7smart Off-line closed system
Features & Benefits
Flow-through Cell (Apparatus 4) instrument with pump and fraction collector including a syringe autosampler Designed for semi-automated USP 4 methods in closed loop with low volume sampling (e.g. Medical Devices and Drug Eluting Stents Elution methods)
Cells available for tablets, capsules, powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices Testing of several dosage forms, including novel dosage forms, in dedicated cells
Ideal for small media volume testing Ideal system for Stents and Medical Devices Elution testing
Sample collection in closed HPLC vials or test tubes with up to 29 rows Allows small volumes sampling during long term testing down to 100 µl or micro liters
Controlled by CE 7smart firmware Password protected methods and printed reports
Built in Needle rinsing system Carry-over prevention
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SOTAX Dissolution Accessories
www.sotax.com
USP 4 Cell Holder Storage Tray
Paddle and Basket Shaft Holder
Rack for Baskets
Media Addition Valve Support
Shaft Cleaning Assembly
Vessel cover
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The most advanced Dissolution software controlling all SOTAX Dissolution system components in single workstation or in client/server modes
WinSOTAXplus Advanced Dissolution Software
WinSOTAX Advanced Dissolution Softwareplus
Features & Benefits
One unified software version for all SOTAX Dissolution semi-automated and fully automated systems Faster Validation training for existing users, quick method transfer from semi-automation to fully-automation
Microsoft SQL server Database Scalable from a single workstation to a lab/department/company network
Validated software with configurable users rights and audit trails, protected database, log files Allows compliance to GxP and 21 CFR part 11
Dissolution Methods linked to System configurations Users only see menus and dialogs which conform to their hardware configuration and user rights
On-line modules for UV-Vis measurements with full scanning for diode array spectrophotmeters Dissolution data fully available on a single window during the test
Various Calibration modes and protocoling of parameters Configurable reports including instrument serial numbers, raw data, concentration and % dissolved, rpm, temperature, calibration data, signatures
Export functionalities Interfaces with LIMS and external softwares/databases/programs
Rack for Baskets
Shaft Cleaning Assembly
Vessel cover
The perfect tool for API Stability Indicating and other Assays
Zymark APW 3
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Features & Benefits
Zymark® APW3
Sample Preparation Workstation designed for Active Pharmaceutical Ingredients (APIs) Assays Fully automated analysis for API stability Indicating Assays and Related Compounds
Capacity for up to 300 samples 300 samples or 150 with a single step dilution can be run unattended
Dual range four to five-place balance Gravimetric confirmation assures liquid are dispensed with accuracy and precision
Dispersing volume from 0.5 to 10 mL in 16 x 100 mm tubes Versatility in applications: API, cleaning validation, low dose or soluble dose assay and uniformity
Sonicating probe with temperature control (optional) Increases the speed of sample extraction with sonication
Sample Analysis by UV or LC. Waters Empower 2 Interface available State of the art analytical integration: archive Samples in Capped HPLC Vials, optional Barcode Reader
Proven third generation TPW 3 Tablet Processing Workstation for automated content uniformity and assay testing
Zymark TPW 3
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Features & Benefits
Fully automated sample preparation workstation for tablets, capsules, powders and suspensions Unattended operation. Fully automated analysis
Automate from 50 to 200 samples without operator intervention Method Development flexibility
Dispersing volume from 50 to 500 mL. Low dose option from 20 to 100 mL Improve robustness of sample preparation methods
Dual range four to five-place balance, three place balance for dispersant solvent Gravimetric confirmation assures liquids are dispensed with accuracy and precision
Network capability Save analyst time for added value tasks
Sample Analysis by UV or LC. Waters Empower 2 Interface available State of the art analytical integration: archive Samples in Capped HPLC Vials, optional Barcode Reader
Zymark® TPW3
SOTAX CTS
SOTAX CTS
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Features & Benefits
Simultaneous sample processing Increased sample throughput and speed of analysis for improved productivity
Sample capacity independant from dilution steps: up to 240 samples in 16 x 160 mm tubes or up to 80 samples in 32 x 115 mm tubes Great flexibility and throughput for the introduction of a wide sample range (tablets, capsules, powder, pellets, liquids, Blend uniformity and effervescent tablet)
Unique vessel design Solvent volumes from 25 to 1000 mL
8-channel Solvent Selector Allows complex methods automation
Built-in ambient temperature sensor Solvent dispensing based on density
Brushless homogenizer motor Maintenance free
Unique cleaning design Minimal solvent comsuption, elimination of carry-over
Off-line sampling with cooling option and injection in UV-Vis or in up to two LC systems Complete flexibility in samples handling and analyzing
Fully controlled by highly secured CT Software including user rights, electronic signatures audit trails Allows 21 CFR part 11 compliance and paperless reporting
High sample throughput for automated content uniformity and assay testing
SOTAX CTS
SOTAX CTS
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Disintegration Testing from basic to automated detection
SOTAX DT 2 Disintegration Testing Apparatus
SOTAX DT 2 Disintegration Testing Apparatus
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Features & Benefits
Disintegration time testing unit with two basket-rack assemblies Allows 3, 6 and 12 sample methods
Each basket-rack assembly can be controlled, started and stopped individually Individual measurement and reported value for each sample
Automatically lowers the baskets at test start and raises the baskets at test end Simplifies basket handling
Optional automated detection of disintegration end point Reproducible results in all media without any interpretation mistake
Conforms to the latest USP <701> and <2040> chapters for disintegration testing Fully compliant in manual and automated modes
Connection to printer Report printout with test results, statistics and temperature protocol
Optional Q-Doc Prolab® quality documentation software Allows 21 CFR part 11 compliance, paperless reporting and LIMS connection
SOTAX HT 1 Manual Tablet Testing System
SOTAX HT 1 Manual Tablet Testing System
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Features & Benefits
Two hardness measurement principles “Constant Speed” or “Constant Force” with a measuring range of up to 500 or 1000 N Can be parametered to match existing tablet testers
Equipped with the Auto Alignment™ device Even the most difficult of tablet shapes are automatically aligned correctly to prevent erroneous hardness measurements
Testing of hardness, thickness, width, diameter or length and weight (with a balance) Testing of five essential physical parameters with results (in Newton, Strong Cobb or Kilopond; mm or inch; mg or g) and statistical data on display which can be printed out on a standard or label printer
Operating conditions are programmable via front keypad with graphic display The program menu allows the user to set specifications for the tablets as T1/T2/T3
Optional Q-Doc Prolab® quality documentation software Allows 21 CFR part 11 compliance, paperless reporting and LIMS connection
Simplified calibration with the SOTAX Automated Dynamic Calibration Tool No weights to carry
Three point calibration and tablet orientation Complies with <USP 1217> and EP 2.9.8
The manual tablet testing system for fast, accurate and trouble-free measurements of all tablet shapes and sizes
SOTAX HT 10 Semi-Automated Testing System
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Features & Benefits
Operating conditions are programmable via front keypad with graphic display The program menu allows the user to set specifications for the tablets as T1/T2/T3
Optional Q-Doc Prolab® quality documentation software Allows 21 CFR part 11 compliance, paperless reporting and LIMS connection
Simplified calibration with the SOTAX Automated Dynamic Calibration Tool No weights to carry
Three point calibration and tablet orientation Complies with <USP 1217> and EP 2.9.8
Two hardness measurement principles “Constant Speed” or “Constant Force” with a measuring range of up to 500 or 1000 N Can be parametered to match existing tablet testers
Tablet Feeder in teflon with engraved numbers Easy to load, remove and clean
Four-station transporter including self-cleaning brushes Accurate automated testing on 20 tablets
Equipped with the Auto Alignment™ device Even the most difficult of tablet shapes are automatically aligned correctly to prevent erroneous hardness measurements
Testing of hardness, thickness, width, diameter or length and weight (with a balance) Testing of five essential physical parameters with results (in Newton, Strong Cobb or Kilopond; mm or inch; mg or g) and statistical data on display which can be printed out on a standard or label printer
SOTAX HT 10 Semi-Automated Testing System
The automated tablet testing system for fast, accurate and trouble-free measurements of all tablet shapes and sizes
SOTAX HT 100 Fully Automated Testing System
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Features & Benefits
Two hardness measurement principles “Constant Speed” or “Constant Force” with a measuring range of up to 500 or 1000 N Can be parametered to match existing tablet testers
The HT 100 has ten chambers with a capacity of 115 mL each (equivalent 200 medium-sized tablets) Automated testing of 10 different batches of tablets, dragées, oblongs, effervescent tablets or similar drug delivery systems
Vibration-free Auto Separator Separates all shapes and sizes of tablets without manual adjustment
Equipped with the Auto Alignment™ device Even the most difficult of tablet shapes are automatically aligned correctly to prevent erroneous hardness measurements
Testing of hardness, thickness, width, diameter or length and weight (with a balance) Testing of five essential physical parameters with results (in Newton, Strong Cobb or Kilopond; mm or inch; mg or g) and statistical data on display which can be printed out on a standard or label printer
Q-Doc Prolab® quality documentation software Allows 21 CFR part 11 compliance, paperless reporting and LIMS connection
Simplified calibration with the SOTAX Automated Dynamic Calibration Tool No weights to carry
Three point calibration and tablet orientation Complies with <USP 1217> and EP 2.9.8
SOTAX HT 100 – Fully Automated Testing System
The fastest automated tablet testing system for fast, accurate and trouble-free measurements of all tablet shapes and sizes batch after batch
To determine the flowability characteristics of blends, powders and granulates simulating processing conditions
SOTAX FT 300 Flowability Tester
SOTAX FT 300 - Flowability Tester
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Features & Benefits
Performs a variety of test conditions including mixing and vibration settings Produces precise, fast and reproductible results on the flowability characteristics of blends, powers and granulates saving time and product
Standardized test conditions Ensure optimum correlation of processing condition and optimal tablet press settings
Vibration and mixing steps pneumatically controlled Operator-independent results, eliminating human error
Q-Doc Prolab® quality documentation software Allows 21 CFR part 11 compliance, paperless reporting and LIMS connection
Includes a Mettler precision balance Accuracy of measurements
Calibration and Qualification procedure Traceability of results
Friability Tester for Single or Dual DrumsSOTAX FT 2 Friability Tester
SOTAX FT 2 - Friability Tester
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Features & Benefits
Front loading with built-in tilt Easy to use with one or two drums
Time, counter, speed modes Flexible operation
Easy to view LCD Display and scroll down menus Designed for the user
Calculation of percent friability and test report printed As per GMP/GLP requirements
Menu guided Qualification procedure Easy Qualification
Designed and manufactured in Switzerland Accurate and robust
The most flexible Tap Density Tester for EP, ASTM, USP I and USP II tests
SOTAX TD 1 Tape Density Tester
SOTAX TD 1 - Tap Density Tester
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Features & Benefits
One single position for all measurements Compliance and simplicity
Easy to view LCD Display and scroll down menus Easy of use
Calculation of results Tapped Density, Compressibility Index and Hausner ratio
RS232 and Ethernet ports for communication Connection to a balance and print-out of results
Qualification procedure Easy Qualification
Quality Management Software for automated control, reporting and data management for the in-process control measurements of tablets
Q-Doc Prolab® Software
Q-Doc Prolab® Software
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Features & Benefits
Microsoft SQL database Full network capability
Designed for the Pharmaceutical Industry Allow compliance to 21 CFR part 11 and to GAMP 4
Automated control of the SOTAX family of hardness testers, disintegration, friability and powder flow testers One single software for use with SOTAX physical testing instruments
Laboratory Monitoring Software System (LMSS) Connection to LIMS System
Modular driver concept Allows simplified integration of new components
SOTAX Services
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SOTAX, as a customer-oriented company, offers comprehensive after sales
service covering installation, maintenance, qualification and repair. An
extensive network of service engineers represents SOTAX all over the
world. In addition to installation, maintenance and repair SOTAX also offers
both operational and performance qualification services (OQ, MQ and PQ).
Thoroughly trained SOTAX specialists qualify the units according to the cGMP
and GAMP guidelines. These SOTAX Service Specialists help our customers
on a daily basis maintaining their procedures, instruments and results in
accordance to the latest Regulation Agencies guidelines.
Installation
SOTAX includes system installation and training with all new purchases. We guarantee you
that the instrument functions to specification and that its users are properly trained. SOTAX
specialists install the systems including the control device and software in the SOTAX test
laboratory prior to shipping to ensure correct functionality to specification. Upon delivery to
the customer’s laboratory the system is installed and again tested to specification prior to train
its users. If the customer wishes, the required operational and / or performance qualification
work can be performed by the SOTAX specialist.
Maintenance
Though SOTAX test instruments are highly reliable and generally trouble-free, regular
anticipated maintenance visits made by specialists are recommended. The FDA requires
routine maintenance procedures for the test instruments for the development and quality
control of the medicaments. If this is not sufficiently performed by laboratories, it can lead to
non-conformance during an audit. SOTAX offers various maintenance solutions. Maintenance
can be performed once or twice a year and can be written into a maintenance contract. The
maintenance work performed is recorded and accepted by that company’s responsible person
and the laboratory is provided with all the necessary documentation in case of an inspection
Qualification
SOTAX offers a calibration and qualification service in accordance with the USP, EP, FDA
and GMP guidelines. This includes Design Qualification (DQ), Installation Qualification (IQ),
Operational Qualification (OQ), Mechanical Qualification (MQ), each with the corresponding
validation documents. In addition the required system suitability test or performance
qualification (PQ) using USP PVT tablets can be performed by our specialists. SOTAX
actively participates in the USP multi-centre studies to determine the limits for these PVT
lots and participates in the FDA collaborative studies. SOTAX qualification specialists
continuously perform these PQ tests and are therefore the most experienced in their
execution. Moreover, SOTAX bears the costs for repeating any PQ test that initially fails
and therefore gives a supplementary qualification guarantee to the customer. SOTAX
also performs MQ testing to the latest ASTM standards and service technicians are
regularly trained to the latest MQ practices. These services are utilized by a wide variety
of companies worldwide.
Repair
If a SOTAX instrument becomes defective, our service technician can repair it on site
or in the SOTAX repair center. SOTAX also offers maintenance and repair contracts to
ensure maximum operational efficiency. Guaranteed reaction times keep fault-related
interruption in use to an absolute minimum.
Contracts
Full service, all maintenance, repair and qualification activities can be covered by a
comprehensive service contract to secure operational readiness. Full service contract:
guaranteed 72-hour reaction time with all services for restoring operational readiness in
the event of a fault, yearly maintenance of the instrument on site and six-month OQ and
PQ, incl. spare parts and travel expenses. Contact us at services@sotax.com to get your
own contract.
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Technical Hotline
Europe / Asia Phone +41 61 487 5460 E-mail services@sotax.com
America Toll Free +1 888 SOTAXUS E-mail sotaxusa@sotax.com
Corporate Mission
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Who we are and what we want
SOTAX leads the way in the development and manufacture of high-quality
pharmaceutical testing equipment and associated services. Our equipment is used
worldwide in the development and production processes of our customers the
pharmaceutical and science industries. SOTAX develops, produces and markets
system solutions for pharmaceutical testing and does so in close cooperation with
pharmaceutical and scientific partners. Our extensive market and process know-
how enables us to meet our customers’ requirements and comply with the key
directives relevant to them. We are also open to cooperation with new industries.
SOTAX is a leading independent company for pharmaceutical testing equipment.
The company owes its independence to its sustained economic success. The SOTAX
Group is a global success story and has subsidiaries around the world who are
familiar with local needs and practices. We maintain our competitive edge by
excelling in flexibility, performance, quality and safety.
Our customers
The customer is in the centre of our activities. His satisfaction is our goal and
quality standard. We set great store by efficiency and professionalism in meeting
customer requirements. We also work with customers to turn visions for our
business operations and future development into reality.
Our employees
SOTAX values skilled, highly capable and enterprising staff who work for the
greater good of the company, combining a sense of individual responsibility with
team spirit. We also encourage creativity and personal skills through ongoing
training.
Our employees cultivate a positive corporate culture through a friendly, open
approach to both their fellow workers and our partners.
Our suppliers
SOTAX sees its relationship with its suppliers as a partnership. Suppliers are expected
to contribute to our joint success through their efficiency and professionalism.
Our environment
We have a keen sense of our economic and social responsibility, and our actions,
products and services make a significant contribution to protecting our environment.
Contacts
Canada
SOTAX (Canada) Ltd. 1-335 Deerhurst Drive CA-Brampton, ON L6T 5K3
Phone +1 905 494 0114 Toll Free +1 866 826 4448 Fax +1 905 494 0723 Toll Free +1 866 767 6077 E-mail sotaxcanada@sotax.com
France
SOTAX Sàrl. 24, avenue de Bâle FR-68300 Saint-Louis
Phone +33 3 8970 0846 Fax +33 3 8970 1781 E-mail info@sotax.com
France
SPS Pharma Services Bâtiment CBRV, 28 Place Henri Dunant FR-63000 Clermont-Ferrand
Phone +33 4 73 17 83 98 Fax +33 4 73 17 83 99 E-mail contact@sps-pharma.com
Austria and Switzerland
SOTAX AG Binningerstrasse 106 CH-4123 Allschwil 1
Phone +41 61 487 5454 Fax +41 61 482 1331 E-mail info@sotax.com
Germany
SOTAX GmbH Wallbrunnstrasse 24 DE-79539 Lörrach
Phone +49 7621 16 5635 Fax +49 7621 16 5715 E-mail info@sotax.com
Asia
SOTAX (Shanghai) Trading Company Ltd. 800 Nanjing Road East Room G, 15/F, No. 1 Plaza CN-200001 Shanghai
Phone +86 21 6352 1008 Fax +86 21 6352 2213 E-mail sotaxchina@sotax.com
33
Great Britain
SOTAX Limited 13 Station Road GB-London N3 2SB
Phone +44 20 8349 6947 Fax +44 20 8349 6948 E-mail info@sotax.com
Italy
SOTAX S.r.l. Via Milazzo 14 IT-24124 Bergamo
Phone +39 035 21 9555 Fax +39 035 21 3643 E-mail sotaxitalia@sotax.com
USA
SOTAX Corporation 68A Elm Street Hopkinton, MA, USA 01748-1668
Phone +1 508 417 1112 Toll Free +1 888 SOTAXUS Tech Support Hotline +1 508 544 4040 Fax +1 508 435 4691 E-mail sotaxusa@sotax.com
SOTAX Horsham 411 Caredean Drive Suite A Horsham, PA 19044-1316
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0-0
302
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www.sotax.com
Technical Hotline
Europe / Asia Phone +41 61 487 5460 E-mail services@sotax.com
America Toll Free +1 888 SOTAXUS E-mail sotaxusa@sotax.com
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